OsteoarthritisRCHNCT00663351

Safety and Effectiveness Study of the Reflection Ceramic Acetabular System

A study testing Reflection Ceramic-Ceramic Total Hip Replacement and Reflection FSO V Total Hip Replacement in people with Osteoarthritis, run by Smith & Nephew, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System. Read more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Osteoarthritis
What is being tested?: Reflection Ceramic-Ceramic Total Hip Replacement and Reflection FSO V Total Hip Replacement
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 456 participants
Where: 7 sitesUnited States
Study dates: Dec 2004to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(Patient must meet all of the following characteristics to be enrolled in the study):
Males and females, 21 to 80 years of age, inclusive;
Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
The patient will be available for follow-up through at least two years postoperative;
The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);
The patient has a total Harris Hip Score of less than or equal to 60 (FDA requirement);
The patient meets none of the exclusion criteria.

Who cannot join

(Patient with any of the following characteristics must be excluded from the study):
Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
Patients with active localized or systemic infection;
Patients who have not reached full skeletal maturity;
Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;

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Immunosuppressive disorders - immunosuppressive disorders are chronic conditions characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), patients receiving therapy to prevent homograft rejection, patients who have acquired immunodeficiency syndrome (AIDS), or auto-immune diseases (except rheumatoid arthritis).
Pregnancy.
Patients with known sensitivity to materials in the device.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Medical College of Georgia, Department of Orthopaedics
Augusta, Georgia, 30912
University of Vermont College of Medicine
Burlington, Vermont, 05405
Family Orthopaedics
Flint, Michigan, 48507
University of Texas Medical Branch, Dept of Orthopaedics and Rehab
Galveston, Texas, 77555
The Memphis Orthopaedic Group, PC
Memphis, Tennessee, 38104
Hospital of Joint Disease, Orthopaedic Institute
New York, New York, 10003
Presbyterian Medical Center, Department of Orthopaedic Surgery
Philadelphia, Pennsylvania, 19104-2699

Other trials in United States

About this study

Official title: Post Approval Study: Reflection Ceramic Acetabular System

This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.

Read the detailed description

This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System. Randomized Non-inflammatory Arthritis, Randomized Inflammatory and Continued Access Cohorts patients previously enrolled in the IDE study will be evaluated annually through five (5) year follow-up. In addition, all patients enrolled in the original study cohorts as well as the continued access patients will be sent a letter questionnaire annually at the 6-10 year postoperative time point to assess the patient's general well-being and if the study components are still in place

Conditions: Osteoarthritis
Being tested: Reflection Ceramic-Ceramic Total Hip Replacement, Reflection FSO V Total Hip Replacement
Keywords: Arthritis, Osteoarthritis, Traumatic Arthritis, Degenerative Joint Disease, Avascular Necrosis
Medical subject headings: Osteoarthritis, Arthritis, Joint Diseases, Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reflection Ceramic-Ceramic Total Hip ReplacementDevice
Also called Hip Replacement, Reflection, ceramic-ceramic
Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.
Reflection FSO V Total Hip ReplacementDevice
Also called Hip replacement, Reflection, ceramic-poly
Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.

Study groups in NCT00663351
Study group	Role	What they receive
Reflection Ceramic-Ceramic Hip System (IP)	Active comparator	Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material. Receives: Device: Reflection Ceramic-Ceramic Total Hip Replacement
Reflection FSO V (5 hole) (Control)	Active comparator	Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome. Receives: Device: Reflection FSO V Total Hip Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival of Hip Implant Based on Number of Hips Requiring Revision
Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm:
RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Measured: Postoperatively through Year 10
Survival of Hip Implant Based on Time Until Revision Required
The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study.
The study arms were further categorized by cohorts within each arm:
RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Measured: Postoperatively through Year 10
Subject Satisfaction Questionnaire
A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10).
The question was asked "Are you satisfied with hip?" and subjects responded either "yes" or "no".
Measured: Year 6 through Year 10 postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Dec 2014

First posted22 Apr 2008 (estimated)
Study startDec 2004
Primary completionOct 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 456 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00663351
Sponsor's protocol ID: PMA 030022
Acronym: RCH
Status last verified: Mar 2015
First submitted: 28 Feb 2008
Last updated: 13 Oct 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Approval Study: Reflection Ceramic Acetabular System
ClinicalTrials.gov ID: NCT00663351
Acronym / sponsor ID: RCH / PMA 030022
Conditions: Osteoarthritis
Keywords: Arthritis, Osteoarthritis, Traumatic Arthritis, Degenerative Joint Disease, Avascular Necrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 456 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Oct 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 22 Apr 2008 (estimated)
Results: Posted 13 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This Post-Approval study is prospective follow-up study designed to evaluate the long-term safety and effectiveness of the Reflection Ceramic Acetabular System.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Reflection Ceramic-Ceramic Hip System (IP)	Active comparator	Device: Reflection Ceramic-Ceramic Total Hip ReplacementInvestigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material.
Reflection FSO V (5 hole) (Control)	Active comparator	Device: Reflection FSO V Total Hip ReplacementControl: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome.

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males and females, 21 to 80 years of age, inclusive;
Primary diagnosis of non-inflammatory arthritis (osteoarthritis) or inflammatory arthritis (rheumatoid arthritis), or patients requiring a revision as specified previously;
The patient or his/her legal guardian is willing to consent to participate in the study by signing and dating the approved consent form;
The patient will be available for follow-up through at least two years postoperative;
The patient has met an acceptable preoperative medical clearance and is free or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk (FDA requirement);

Key exclusion criteria (9 listed)

Patients known to have insufficient quantity or quality of bone support resulting from Conditions such as cancer, femoral osteotomy, Girdlestone resection, significant osteoporosis or metabolic disorders of calcified tissues. Patients with physical conditions tending to place extreme loads on implants such as morbid obesity (> 100 pounds over desirable body weight), Charcot joints, muscle deficiencies, or multiple joint disabilities;
Patients with active localized or systemic infection;
Patients who have not reached full skeletal maturity;
Patient psychological or neurological conditions which tend to preempt the patient's ability or willingness to restrict activities or follow medical advice, especially during the postoperative period, e.g.: drug or alcohol abuse, serious mental illness or retardation, or general neurological conditions;
The patient is participating in any other pharmaceutical, biologic or medical device clinical investigation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reflection Ceramic-Ceramic Total Hip ReplacementAlso: Hip Replacement, Reflection, ceramic-ceramicIntervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.	Device	Reflection Ceramic-Ceramic Hip System (IP)
Reflection FSO V Total Hip ReplacementAlso: Hip replacement, Reflection, ceramic-polyIntervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem.	Device	Reflection FSO V (5 hole) (Control)

Primary outcome

Survival of Hip Implant Based on Number of Hips Requiring Revision
Time frame: Postoperatively through Year 10
Revisions were assessed cumulatively from Initial Study Period through Post-Approval Study Period and End of Study/Withdrawal. Implant survival was analyzed based on the number of hip revisions that occurred as well as the cohort for each study arm (IP and Control), but further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Survival of Hip Implant Based on Time Until Revision Required
Time frame: Postoperatively through Year 10
The survival of the implant was analyzed based on the length of time postoperatively until hip revision surgery was required (cumulatively through Initial Study Period and Post-Approval Study Period) for participants who required a revision surgery during the course of the study. The study arms were further categorized by cohorts within each arm: RNIA = randomized, non-inflammatory arthritis cohort (IP or Control) RIA = randomized, inflammatory arthritis cohort (IP or Control) RR = revision cohort (IP or Control) CAC = continued access cohort (IP only)
Subject Satisfaction Questionnaire
Time frame: Year 6 through Year 10 postoperatively
A subject satisfaction questionnaire was conducted at Year 6, Year 7, Year 8, Year 9, and Year 10 postoperatively. The questionnaire was mailed to enrolled subjects each year (Years 6-10). The question was asked "Are you satisfied with hip?" and subjects responded either "yes" or "no".

Results and safety

Results posted to the registry on 13 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reflection Ceramic-Ceramic Hip System (IP)	308	298
Reflection FSO V (5 Hole) (Control)	148	129

Primary outcome: Survival of Hip Implant Based on Number of Hips Requiring Revision

Time frame: Postoperatively through Year 10. Count of units. Unit: Hips

Measure	Reflection Ceramic-Ceramic Hip System (IP) n = 298	Reflection FSO V (5 Hole) (Control) n = 129
Hips Requiring Revision: RNIA Cohort	12	9
Hips Requiring Revision: RIA Cohort	2	1
Hips Requiring Revision: RR Cohort	0	0
Hips Requiring Revision: CAC Cohort	15	0
Hips Not Requiring Revision: RNIA Cohort	156	118
Hips Not Requiring Revision: RIA Cohort	17	9
Hips Not Requiring Revision: RR Cohort	5	7
Hips Not Requiring Revision: CAC Cohort	157	0

Population analysed: All hips/participants were assessed using the ITT population, which excluded 29 enrolled participants from analysis not meeting ITT criteria.

Primary outcome: Survival of Hip Implant Based on Time Until Revision Required

Time frame: Postoperatively through Year 10. Number. Unit: survival time in years

Measure	Reflection Ceramic-Ceramic Hip System (IP) n = 29	Reflection FSO V (5 Hole) (Control) n = 10
Hip ID 168 (RNIA cohort)	0.0	–
Hip ID 239 (RNIA cohort)	–	0.0
Hip ID 318 (RNIA cohort)	–	0.0
Hip ID 221 (RIA cohort)	0.0	–
Hip ID 348 (CAC cohort)	0.0	–
Hip ID 408 (CAC cohort)	0.0	–
Hip ID 448 (CAC cohort)	0.0	–
Hip ID 113 (RNIA cohort)	0.1	–

Population analysed: Analysis is presented by individual hip ID numbers to demonstrate time before a revision was required as well as the corresponding cohorts of each. All hips/participants were assessed using the ITT population, which excluded 29 enrolled participants from analysis not meeting ITT criteria.

Primary outcome: Subject Satisfaction Questionnaire

Time frame: Year 6 through Year 10 postoperatively. Count of participants. Unit: Participants

Measure	Reflection Ceramic-Ceramic Hip System (IP) n = 298	Reflection FSO V (5 Hole) (Control) n = 129
Year 6 - "Are you satisfied with hip?": Yes	107	25
Year 6 - "Are you satisfied with hip?": No	3	0
Year 7 - "Are you satisfied with hip?": Yes	179	47
Year 7 - "Are you satisfied with hip?": No	11	4
Year 8 - "Are you satisfied with hip?": Yes	177	45
Year 8 - "Are you satisfied with hip?": No	17	3
Year 9 - "Are you satisfied with hip?": Yes	189	49
Year 9 - "Are you satisfied with hip?": No	19	1

Population analysed: The number analyzed include all enrolled subjects who responded to the questionnaire at each time point.

Adverse events

Time frame: AEs were collected from enrollment through the end of the study/subject withdrawal whichever came first (up to 10 years). However, after the 5-year study report was presented to the FDA, only subject deaths were collected for AEs. The 6-10 year study requirement from the FDA included revision information, deaths, and subject satisfaction collection only.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reflection Ceramic-Ceramic Hip System (IP)	18 of 308 (5.8%)	0 of 308 (0%)	18 of 308
Reflection FSO V (5 Hole) (Control)	7 of 148 (4.7%)	0 of 148 (0%)	7 of 148

Limitations and caveats (from the sponsor): There were no limitations or caveats determined during the course of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Scott Corpe, M.D. principal investigator

Medical College of Georgia, Dept of Orthopaedic

Joseph Zuckerman, M.D. principal investigator

Hospital of Joint Disease, Orthopaedic Institute

Jonathan P Garino, M.D. principal investigator

Presbyterian Medical Center, Dept of Orthopaedic

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reflection Ceramic-Ceramic Total Hip Replacement and Reflection FSO V Total Hip Replacement in people with Osteoarthritis, run by Smith & Nephew, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival of Hip Implant Based on Number of Hips Requiring Revision (time frame: Postoperatively through Year 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00663351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.